Researchers have developed a new shorter and simpler consent form template for cancer patients invited to participate in phase I clinical trials.
The new form is available in English and Spanish and is written in a language that does not exceed an eighth-grade reading level, according to a report published in the July-August 2009 issue of IRB: Ethics and Human Research (2009, Vol. 31:4). By excluding features that are only relevant to phase II and phase III trials, it is easier to understand and has been shortened from an average of seven pages to five pages.
The form was developed by researchers from the National Institutes of Health (NIH) in Rockville, MD; Cleveland Clinic in Cleveland; and Memorial Sloan-Kettering Cancer Center in New York City. The report's principal author was Dr. Shlomo Koyfman from the radiation oncology department of the Cleveland Clinic.
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